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16/09/2025

Vanda Pharmaceuticals (VNDA) A Risky PDUFA Play with Strong Upside

Two FDA decisions ahead Tradipitant (Motion Sickness) Dec 30, 2025 and Bysanti (Bipolar I & Schizophrenia) Feb 21, 2026. Back-to-back catalysts with high risk and strong upside.
#pdufa read here
16/09/2025

Innoviva’s Zoliflodacin Oral Gonorrhea Drug Faces FDA Decision Dec 15, 2025

Zoliflodacin could become the first oral single-dose treatment for resistant gonorrhea.
#pdufa read here
10/09/2025

Denali Therapeutics (DNLI) PDUFA Jan 5 2026 First BBB-Penetrant ERT for Hunter Syndrom

Here’s why I see strong upside for Denali with the upcoming FDA PDUFA decision for Tividenofusp alfa in Hunter syndrome (MPS II) and the potential to redefine the standard of care.
#pdufa read here
10/09/2025

Corcept Therapeutics. Two Key PDUFA Catalysts Ahead

Here’s why I see big upside for Corcept with two upcoming FDA PDUFA decisions for Endogenous Cushing’s syndrome and Platinum-resistant ovarian cancer.
#pdufa read here
10/09/2025

Why Omeros December 2025 PDUFA for Narsoplimab Could Be Transformational

Omeros is approaching a pivotal FDA decision on narsoplimab for TA-TMA. Here’s why this binary event could be a major market mover.
#pdufa read here

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